Prolato Clinical Research Center | Houston, TX
Status and phase
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About
We are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes. We are doing this by looking into how semaglutide works in the kidneys.
Participants will either get semaglutide or placebo (a 'dummy' medicine) - which treatment participants get is decided by chance.
Semaglutide is a medicine doctors can prescribe in some countries for the treatment of type 2 diabetes.
Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine into the skin once a week.
The study will last for about 1 year. Participants will have 11 visits to the clinic, and 2 phone visits. Some of the visits could be in different locations.
Study staff will take blood samples at most of these visits. At 9 visits, participants will be asked to bring a sample of their first morning urine. At 4 of the visits participants will have to bring urine that they have collected over the last 24 hours.
The study includes magnetic resonance imaging (MRI) scans of participants' kidneys which is a test that shows a detailed picture of organs and other parts inside the body. The scan will last for 30 minutes, and is free of radiation.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female.
Age above or equal to 18 years at the time of signing informed consent.
Diagnosed with T2D (type 2 diabetes) greater than or equal to 180 days prior to the day of screening.
HbA1c (glycated haemoglobin) below or equal to 9.0 percent (below or equal to 75 mmol/mol).
Depending on biopsy/non-biopsy population:
UACR ( Urinary albumin-to-creatinine ratio ) greater than or equal to 20 and below 5000 mg/g.
Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)) unless such treatment is contraindicated or not tolerated.Treatment dose must be stable for at least 28 days prior to screening.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
105 participants in 2 patient groups, including a placebo group
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Central trial contact
Novo Nordisk
Data sourced from clinicaltrials.gov
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